The present disclosure relates generally to medical devices and methods, and in certain aspects to methods and devices for retaining a plug or similar device in place to maintain hemostasis after a procedure that disrupts a vascular vessel, and in particular embodiments after a percutaneous vascular intervention procedure.
Vascular disease is one of the leading causes of deaths today. In many instances, such a disease requires the insertion of a medical device into the lumen of a vascular vessel. Depending on the size of the opening required to insert the medical device into the vessel, and depending on the type of vessel (i.e., vein vs. artery), these openings can cause a variety of complications, including access site bleeding and/or infection. Many types of arteriotomy closure devices exist, and they can be constructed of a variety of materials and can be used in a variety of different ways to achieve hemostasis. For example, in a percutaneous coronary intervention, a device is inserted into the femoral artery. When this device is withdrawn from the artery, methods must be taken to control the exit of blood from the artery or the patient would require a blood transfusion.
Historically, the most common approach to control this problem involved the practitioner simply applying manual compression to the access site until the wound has had a chance to heal itself sufficiently. More recently, a puncture closing device, such as a hemostatic patch or plug, is inserted into the opening of the vessel. The hemostatic plug is typically formed of a bioresorbable material such that it can degrade in vivo and its removal from the patient is unnecessary. The plug stays in place long enough to control bleeding and then degrades over time. The problem with this technique is that the patch or plug can become dislodged from the vessel opening, thereby requiring further action to control the bleeding.
Although vascular closure devices exist, there remain needs for improved and/or alternative devices for maintaining hemostasis, as well as methods for making and using the same.